Evaluation of the Effectiveness of an Alcohol Based Hand Gel for the Reduction of Warts on the Hands
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Difference in % Reduction in Wart Size Between Product A and Product B at Each Timepoint
研究概览
简要总结
The objective is to conduct a pilot study to determine the effectiveness of PURELL VF481 to treat warts located on the hands.
详细描述
- At least 5, but not more than 20 participants will be enrolled in the study.
- Each wart is randomly assigned a test product prior to the start of the study
- Warts are equally distributed between products so that an equal number of warts treated on each person. One (1) product will be assigned to each hand to minimize treatment confusion for the participants
- The test product will be applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage.
- Subjects will log date and time of application and anything notable (such as changes in wart appearance or missed dose) in a log book.
- Measurement of wart (longest diameter) and photos taken at each visit by trained office medical assistants, LPNs, PA-C or MD.
- Time points for office visitation: Baseline (0 weeks), 4 weeks, 8 weeks, 12 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with 2+ warts being seen at a Dermatologist's office
- •2 or more warts on the hands that are located at least 1 cm apart or on separate fingers
- •Warts must have been present for at least 2 months
- •Wart size must be between 2 mm-15 mm in diameter
- •Participants must be in good general health
- •Participants must be able to speak and read in English.
- •Participant must be able to read and sign participant instruction sheet, and informed consent and authorization.
- •Subjects must be able to understand and execute the instructions presented in pictorial form.
排除标准
- •Pregnancy (Patients will be asked to verify using criteria of contraception, menstrual cycle, and pregnancy test, if necessary).
- •Treatment of warts with other methods such as salicylic acid, etc., in the past 14 days.
- •Known allergies to common topical antimicrobials or the individual ingredients in either test product.
- •Participation in a clinical study in the past 7 days or participation in another clinical study
- •Unwillingness to perform requirements of the study
- •Any medical condition that should preclude participation in the study, at the discretion of the physician
- •Missed ≥ 6 of the treatments in a 4 week study period
研究组 & 干预措施
PURELL Left Hand/ Placebo Right Hand
One product will be assigned to each hand to minimize treatment confusion for the participants.
PURELL VF481 Left Hand/ Placebo Right Hand
干预措施: PURELL VF481 (Other)
PURELL Left Hand/ Placebo Right Hand
One product will be assigned to each hand to minimize treatment confusion for the participants.
PURELL VF481 Left Hand/ Placebo Right Hand
干预措施: Placebo Solution (Other)
Placebo Solution Left Hand/ PURELL Right hand
One (1) product will be assigned to each hand to minimize treatment confusion for the participants PURELL VF481 Right Hand/ Placebo Left Hand
One (1) pump of test product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed
干预措施: PURELL VF481 (Other)
Placebo Solution Left Hand/ PURELL Right hand
One (1) product will be assigned to each hand to minimize treatment confusion for the participants PURELL VF481 Right Hand/ Placebo Left Hand
One (1) pump of test product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed
干预措施: Placebo Solution (Other)
结局指标
主要结局
Difference in % Reduction in Wart Size Between Product A and Product B at Each Timepoint
时间窗: Baseline, 4, 8, and 12 weeks, change at 12 weeks reported
Data is not available due to study closure and data destruction
次要结局
- Change in Size of Warts Treated by Each Product at Each Time Point.(Baseline, 4, 8 and 12 weeks, change at 12 weeks reported)